Tepkinly

/ AbbVie

See prescribing information for full details

Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B cell lymphoma after two or more lines of systemic therapy.
As monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Hypersensitivity to the active substance or to any of the excipients

Cytokine release syndrome (CRS)
CRS, which may be life-threatening or fatal, occurred in patients receiving epcoritamab. The most common signs and symptoms of CRS include pyrexia, hypotension and hypoxia. Other signs and symptoms of CRS in more than two patients include chills, tachycardia, headache and dyspnoea. Most CRS events occurred in Cycle 1 and were associated with the first full dose of epcoritamab. Administer prophylactic corticosteroids to mitigate the risk of CRS. At the first signs or symptoms of CRS, treatment should be instituted of supportive care with tocilizumab and/or corticosteroids as appropriate.
Patients with DLBCL should be hospitalised for 24 hours after administration of the Cycle 1 Day 15 dose of 48 mg to monitor for signs and symptoms of CRS.
Haemophagocytic lymphohistiocytosis (HLH)
Haemophagocytic lymphohistiocytosis (HLH), including fatal cases, have been reported in patients receiving epcoritamab. HLH is a life-threatening syndrome characterised by fever, skin rash, lymphadenopathy, hepato- and/or splenomegaly and cytopenias. HLH should be considered when the presentation of CRS is atypical or prolonged. For suspected HLH, epcoritamab must be interrupted for diagnostic workup and treatment for HLH initiated.
Immune effector cell-associated neurotoxicity syndrome (ICANS)
ICANS, including fatal events, have occurred in patients receiving epcoritamab. ICANS may manifest as aphasia, altered level of consciousness, impairment of cognitive skills, motor weakness, seizures, and cerebral oedema.
The majority of cases of ICANS occurred within Cycle 1 of epcoritamab treatment, however some occurred with delayed onset.
At the first signs or symptoms of ICANS, treatment with corticosteroids and non-sedating-anti-seizure medicinal products should be instituted as appropriate.
Patients with DLBCL should be hospitalised for 24 hours after administration of the Cycle 1 Day 15 dose of 48 mg to monitor for signs and symptoms of ICANS.
Serious infections
Treatment with epcoritamab may lead to an increased risk of infections. Serious or fatal infections were observed in patients treated with epcoritamab in clinical studies.
Administration of epcoritamab should be avoided in patients with clinically significant active systemic infections.
As appropriate, prophylactic antimicrobials should be administered prior to and during treatment with epcoritamab. In the event of febrile neutropenia, patients should be evaluated for infection and managed with antibiotics, fluids according to local guidelines. Cases of progressive multifocal leukoencephalopathy (PML), including fatal cases, have been reported in patients treated with epcoritamab who have also received prior treatment with other immunosuppressive medications. If neurological symptoms suggestive of PML occur during epcoritamab therapy, treatment with epcoritamab should be discontinued and appropriate diagnostic measures initiated.
Tumour lysis syndrome (TLS)
TLS has been reported in patients receiving epcoritamab. Patients at an increased risk for TLS are recommended to receive hydration and prophylactic treatment with a uric acid lowering agent. Patients should be monitored for signs or symptoms of TLS, especially patients with high tumour burden or rapidly proliferative tumours, and patients with reduced renal function.
Tumour flare
Tumour flare has been reported in patients treated with epcoritamab. Manifestations could include localised pain and swelling. Consistent with the mechanism of action of epcoritamab, tumour flare is likely due to the influx of T-cells into tumour sites following epcoritamab administration.
Immunisation
Live and/or live-attenuated vaccines should not be given during epcoritamab therapy. Studies have not been conducted in patients who received live vaccines.
See prescribing information for full details.

The most common adverse reactions (≥ 20%) were CRS, injection site reactions, fatigue, viral infection, neutropenia, musculoskeletal pain, pyrexia and diarrhoea.
See prescribing information for full details.

No interaction studies have been performed.
Transient elevation of certain proinflammatory cytokines by epcoritamab may suppress CYP450 enzyme activities. On initiation of epcoritamab therapy in patients being treated with CYP450 substrates with a narrow therapeutic index, therapeutic monitoring should be considered.

Women of childbearing potential/Contraception in females
Women of childbearing potential should be advised to use effective contraception during treatment with epcoritamab and for at least 4 months after the last dose. Verify pregnancy status in females of reproductive potential prior to initiating epcoritamab treatment.
Pregnancy: Based on its mechanism of action, epcoritamab may cause foetal harm, including B-cell lymphocytopenia and alterations in normal immune responses, when administered to pregnant women. There are no data on the use of epcoritamab in pregnant women. Epcoritamab is not recommended during pregnancy and in women of childbearing potential not using contraception.
Lactation: It is not known whether epcoritamab is excreted in human milk or its effect on milk production. Since IgGs are known to be present in milk, neonatal exposure to epcoritamab may occur via lactational transfer. Breast-feeding should be discontinued during treatment with epcoritamab and for at least 4 months after the last dose.

In the event of overdose, monitor the patient for any signs or symptoms of adverse reactions and administer appropriate supportive treatment.

Epcoritamab has major influence on the ability to drive and use machines. Due to the potential for ICANS, patients receiving epcoritamab are at risk of altered level of consciousness. Patients should be advised to exercise caution while (or avoid if symptomatic) driving, cycling or using heavy or potentially dangerous machines.